Method and system for recording sterilization data of sterilization cabinet

Through the direct interaction between the database and PLC, the problem of inaccurate sterilization recording time is solved, the accuracy and flexibility of sterilization recording are achieved, and it is suitable for sterilization cabinet data recording in the field of industrial control data processing.

CN120340147APending Publication Date: 2025-07-18TRUKING TECH LTD
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Patent Information

Application Number
CN202510388209.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-31
Publication Date
2025-07-18

AI Technical Summary

Technical Problem

The sterilization recording time in traditional pharmaceutical data recording schemes is inaccurate and inflexible, which affects the safe production of drugs.

Method used

Through the database and PLC, the PLC switches instantaneous recording time and data during the sterilization phase. Combined with the TDS protocol, it allows an error range of ±400 milliseconds, and records historical data in a fixed period, avoiding middleware and dynamically adjusting the recording period.

Benefits of technology

Improves the accuracy and flexibility of sterilization recording time, ensures time and data consistency, and reduces timing errors and software downtime requirements.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a sterilization cabinet sterilization data recording method and system, a database and a PLC directly perform data interaction, and the method comprises the following steps: a pulsating vacuum steam sterilization cabinet operates according to formula data; when the pressure value and the temperature value of the equipment reach set values, the PLC records the starting time and starting data of the sterilization stage and sends the starting time and starting data to a database; when the set running time or the set F0 value is reached, the PLC records the end time and end data of the sterilization stage, and sends the end time and end data to the database; and according to the start time and the end time stored in the database, carrying out statistics to obtain the actual duration of the sterilization stage so as to form report data of the sterilization stage. The problem that the sterilization recording time is not accurate is solved.
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Description

Technical Field

[0001] The present invention relates to the technical field of industrial control data processing, and particularly to a method and system for recording sterilization data of a sterilizer cabinet. Background Art

[0002] The records and data of drug production inspection are the only vouchers for an enterprise to produce in compliance with laws and regulations, and are the key source for the full traceability of drug safety. Data management is crucial in the pharmaceutical production process. For example, for a pulsating vacuum steam sterilizer cabinet, the sterilization time needs to be strictly controlled. If the recorded sterilization time is inaccurate, it may affect the sterilization effect and the safe production of drugs. However, through long-term production practice by the inventor, it is found that traditional pharmaceutical data recording schemes often still have the problems of inaccurate recording time and large errors, as Figure 1-2 shown; in addition, the frequency of the historical data recording cycle only takes effect after the software is closed and restarted, and cannot take effect immediately after being changed, making it inflexible to use. Summary of the Invention

[0003] (1) Technical Problems to be Solved

[0004] Based on the above problems, the present invention provides a method and system for recording sterilization data of a sterilizer cabinet to solve the problem of inaccurate sterilization recording time.

[0005] (2) Technical Solutions

[0006] Based on the above technical problems, the present invention provides a method for recording sterilization data of a sterilizer cabinet, in which the database and the PLC directly perform data interaction, including:

[0007] The pulsating vacuum steam sterilizer cabinet operates according to the formula data;

[0008] When the pressure value and temperature value of the equipment reach the set values, the PLC records the start time and start data of the sterilization stage and sends them to the database; when the set running time or the set F0 value is reached, the PLC records the end time and end data of the sterilization stage and sends them to the database;

[0009] The actual duration of the sterilization stage is statistically obtained based on the start time and end time stored in the database, and the report data of the sterilization stage is formed thereby.

[0010] Further, the database and the PLC directly perform data interaction through the TDS protocol.

[0011] Further, it further includes: the PLC records the corresponding historical data according to the historical record cycle and sends the historical data and the corresponding time to the database.

[0012] Further, the historical record cycle is adjustable.

[0013] Further, the start time of the sterilization stage is between the corresponding minute + corresponding second + 400 to 600 milliseconds.

[0014] Further, the set value of the pressure is 1.05 bar, and the set value of the temperature is 121.0 °C.

[0015] Further, the set F0 value is 12.0 min, and the set running time is 30 min.

[0016] Further, the pulsating vacuum steam sterilizer can select the working process. The working process includes multiple stages. The PLC records the corresponding time and data simultaneously at the changing moment of each stage, obtains the start time, start data, end time, and end data of each stage, and sends them to the database. The changing moment of each stage is when the set operating conditions of each stage are met.

[0017] Further, the working process includes "sterilization", "vacuum leak test", and "filter sterilization". The "sterilization" includes "liquid sterilization", "solid sterilization", and "BD sterilization". The stages included in the "liquid sterilization" are: standby, preheating, replacement, temperature rise, sterilization, exhaust, and recompression; the stages included in the "solid sterilization" are: standby, preheating, pulsation, temperature rise, sterilization, exhaust, drying, pulsating drying, and recompression; the stages included in the "BD sterilization" are: standby, preheating, pulsation, temperature rise, sterilization, exhaust, drying, and recompression; the stages included in the "vacuum leak test" are: standby, evacuation, pressure stabilization, leak test, and recompression; the stages included in the "filter sterilization" are: standby, pressure balance, temperature rise, sterilization, cooling, and recompression.

[0018] The present invention also discloses a sterilization data recording system for a sterilizer, which runs the sterilization data recording method of the sterilizer.

[0019] (3) Beneficial effects

[0020] The above technical solution of the present invention has the following advantages:

[0021] (1) The technical problems of the present invention are not easy to discover. The database and the PLC directly perform data interaction through the TDS protocol without middleware. The PLC records the time and data at the moment of switching between sterilization stages, making the recording of time and data consistent, effectively avoiding the difference between the statistical result time and the set time caused by the failure to record the data at the moment of stage switching, and both the time and data are generated by the PLC, effectively avoiding the difference between the statistical result time and the set time caused by the time and data not being generated simultaneously, thereby improving the accuracy of the sterilization recording time.

[0022] (2) The start time of the sterilization stage of the present invention is initiated between adding 400 to 600 milliseconds to the corresponding time, with an allowable error range of ±400 milliseconds, effectively avoiding the difference between the statistical result time and the set time caused by the timing error inside the PLC program, and further improving the accuracy of the sterilization record time;

[0023] (3) The present invention records historical data by the PLC at a fixed cycle and can dynamically adjust the historical data recording cycle of the PLC without software shutdown, thereby improving the flexibility of changing the historical recording cycle. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The features and advantages of the present invention will be more clearly understood by referring to the accompanying drawings. The drawings are schematic and should not be construed as imposing any limitation on the present invention. In the drawings:

[0025] Figure 1 is the sterilization setting table of the sterilization cabinet of the prior art of the present invention;

[0026] Figure 2 is the schematic diagram of the sterilization data statistics of the sterilization cabinet of the prior art of the present invention;

[0027] Figure 3 is the overall process schematic diagram of the sterilization data recording method of the sterilization cabinet of the prior art of the present invention;

[0028] Figure 4 is the overall process schematic diagram of the sterilization data recording method of the sterilization cabinet in the embodiment of the present invention;

[0029] Figure 5 is the process schematic diagram of the sterilization data recording method in the sterilization stage of the sterilization cabinet in the embodiment of the present invention;

[0030] Figure 6 is the schematic diagram of the sterilization data statistics of the sterilization cabinet in the embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0031] The following will further describe in detail the specific embodiments of the present invention in conjunction with the drawings and embodiments. The following embodiments are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0032] In the prior art, such as Figure 3As shown in the figure, there is a database, a PLC, and an SCADA middleware. The SCADA middleware includes SCADA variable management and SCADA archive management. The internal variable clock of the SCADA variable management regularly requests the PLC to read the variable values of the PLC, caches the variable values returned by the PLC in the SCADA variable management. The archive clock inside the SCADA archive management regularly reads the variable values and the corresponding variable times cached in the SCADA variable management, and then sends them to the database. Finally, according to the variable values and variable times stored in the database, corresponding to each stage in the sterilizer working process, the start time, start data, end time, and end data of each stage are extracted, and the actual duration is calculated based on the start time and end time of each stage.

[0033] As can be seen from the above, there are roughly two reasons for inaccurate and large-error recorded times: The first is that the data at the moment of stage switching is not read and recorded by the SCADA variable management from the PLC, resulting in a mismatch between the statistical result time and the set time. For example, the set sterilization time is 30 minutes, the start time of data statistics is 16:42:13, the end time is 17:12:00, and the recorded sterilization time is 29 minutes and 48 seconds, which does not match the set time of 30 minutes. The second is that the recorded time and data are not generated simultaneously. The data is provided by the PLC, and the time is provided by the SCADA software of the upper computer. The recorded data and time are not exactly matched, with a small error, and this error is likely to cause differences when switching seconds. For example, the data is generated at the 1st second, but the recorded time is the 2nd second.

[0034] In addition, if the internal timing of the PLC is used, there is an error in the internal timing of the PLC. The internal clock of the PLC is accurate to milliseconds, while the recorded time is only accurate to seconds. For example, a certain stage starts at 0 minutes, 0 seconds, 0 milliseconds and is required to last for 30 minutes. However, due to the PLC error, at the end, it is at 29 minutes, 59 seconds, 999 milliseconds. When using seconds for statistics, the duration is 29 minutes and 59 seconds, which does not match the required 30 minutes.

[0035] The embodiment of the present invention does not require SCADA software, reducing intermediate links, including a database and a PLC. The database and the PLC directly perform data interaction through the TDS protocol. The database is SQL Server, as Figure 4 shown, an embodiment of the sterilizer sterilization data recording method includes the following steps:

[0036] S1. The pulsating vacuum steam sterilizer operates according to the recipe data;

[0037] The pulsating vacuum steam sterilizer can select different working processes, and the working processes include "sterilization", "vacuum leak test" and "filter sterilization". The "sterilization" includes three sterilization types, including: "liquid sterilization", "solid sterilization" and "BD sterilization". The "liquid sterilization", "solid sterilization", "BD sterilization" and "filter sterilization" all have multiple stages including the sterilization stage;

[0038] For each working process, the included stages run in a fixed order in sequence. The stages included in the "liquid sterilization" are: standby, preheating, replacement, heating up, sterilization, exhaust and recompression; the stages included in the "solid sterilization" are: standby, preheating, pulsation, heating up, sterilization, exhaust, drying, pulsating drying and recompression; the stages included in the "BD sterilization" are: standby, preheating, pulsation, heating up, sterilization, exhaust, drying and recompression; the stages included in the "vacuum leak test" are: standby, evacuation, pressure stabilization, leak test and recompression; the stages included in the "filter sterilization" are: standby, pressure balance, heating up, sterilization, cooling and recompression.

[0039] S2. When the pressure value and temperature value of the equipment reach the set values, the PLC records the start time and start data of the sterilization stage and sends them to the database; when the set running time or the set F0 value is reached, the PLC records the end time and end data of the sterilization stage and sends them to the database;

[0040] For the sterilization stage, when the pressure value, temperature value and duration value of the equipment reach the set values, it enters the sterilization stage. At this time, the PLC simultaneously records the start time and start data of the sterilization stage and sends them to the database; when the set running time or the set F0 value (the F0 value is the standard sterilization time) is reached, the PLC simultaneously records the end time and end data of the sterilization stage and sends them to the database; the start time and start data of the sterilization stage are generated by the PLC simultaneously, and the end time and end data are also generated by the PLC simultaneously, ensuring that the recorded time and data are generated simultaneously, and ensuring that the data and time at the moment of switching of the sterilization stage are all read and recorded.

[0041] In this embodiment, as Figure 5As shown, it is determined whether the current is the sterilization stage. If it is not the sterilization stage, when the pressure value and temperature value of the equipment reach the set values required for sterilization, the set value of the pressure value is 1.05 bar and the set value of the temperature value is 121.0 °C, then it enters the sterilization stage, and the PLC records the start time and start data of the sterilization stage. If it is the sterilization stage, it is determined whether to use the F0 value control. If so, when the F0 value reaches the set value, the set F0 value is 12.0 min, then the sterilization stage ends and it enters the next stage, and the PLC records the end time and end data of the sterilization stage. If not, when the sterilization time reaches the set running time, the set running time is 30 min, then the sterilization stage ends and it enters the next stage, and the PLC records the end time and end data of the sterilization stage. For other stages except the sterilization stage, similarly, at the moment of change of each stage, that is, when the set operating conditions requirements of each stage are met, the PLC records the start time and start data of each stage and sends them to the database. When the set running time is reached, the PLC records the end time and end data of each stage and sends them to the database. The various stages corresponding to the work process run in sequence according to the set order. The moment of change of each stage includes the start moment and the end moment. The end time and end data of the previous stage are the start time and start data of the next stage. Therefore, only by the PLC recording the time and data at the moment of change of each stage can the start time, start data, end time and end data of each stage be recorded.

[0042] Furthermore, the internal clock of the PLC is accurate to milliseconds, while the recorded time is only accurate to seconds. To overcome the internal timing error of the PLC program, the start moment of each stage including the sterilization stage is set to be between the corresponding minute + corresponding second + 400 - 600 milliseconds, with an allowable error range of plus or minus 400 milliseconds, so that the end moment is displayed correctly.

[0043] For example: If the sterilization stage starts at 0 minutes 0 seconds 500 milliseconds and is to end after 30 minutes, then when counting, 30 minutes 0 seconds 0 milliseconds is 30 minutes 0 seconds, and 30 minutes 0 seconds 999 milliseconds is also 30 minutes 0 seconds. Even if there is an internal timing error in the PLC program, the recorded start time is 0 minutes 0 seconds and the recorded end time is 30 minutes 0 seconds, meeting the set 30 minutes. Similarly, if the sterilization stage starts at 12 minutes 50 seconds 600 milliseconds and is to end after 30 minutes, then when counting, 42 minutes 50 seconds 0 milliseconds is 30 minutes 0 seconds, and 42 minutes 50 seconds 0 milliseconds 999 milliseconds is also 42 minutes 50 seconds. Even if there is an internal timing error in the PLC program, the recorded start time is 12 minutes 50 seconds and the recorded end time is 42 minutes 50 seconds, meeting the set 30 minutes. It is so stable and controllable that it is not a probabilistic event.

[0044] Further, starting from the operation of the workflow, the PLC records the corresponding historical data according to the historical record period, and directly sends the historical data and the corresponding time to the database, and the historical record period is adjustable;

[0045] The historical record clock of the PLC starts from the beginning of the workflow. When each record period is satisfied, the time and data are recorded and directly sent to the database by the PLC; thus, the historical data record period of the PLC can be dynamically adjusted without software shutdown.

[0046] S3. According to the start time and end time stored in the database, the actual duration of the sterilization stage is statistically obtained, and the report data of the sterilization stage is formed accordingly.

[0047] In this embodiment, the actual duration of each stage is statistically obtained according to the start time and end time of each stage. As Figure 6 shown, the actual duration of the sterilization stage is the same as the set running time.

[0048] Finally, it should be noted that the above method can be converted into software program instructions, which can be implemented by using a system including a processor and a memory, or can be implemented by computer instructions stored in a non-transitory computer-readable storage medium. The above-mentioned integrated unit implemented in the form of a software functional unit can be stored in a computer-readable storage medium. The above-mentioned software functional unit is stored in a storage medium, including several instructions for causing a computer device (which can be a personal computer, a server, or a network device, etc.) or a processor to execute some steps of the methods described in various embodiments of the present invention. The foregoing storage medium includes: various media such as USB flash drives, mobile hard disks, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical discs that can store program codes.

[0049] In summary, through the above-mentioned method and system for recording sterilization data of a sterilization cabinet, the following beneficial effects are obtained:

[0050] (1) The technical problems of the present invention are not easy to discover. The database and the PLC directly perform data interaction through the TDS protocol without an intermediate layer. The PLC records the time and data at the moment of switching in the sterilization stage, so that the recording of time and data is consistent, effectively avoiding the difference between the statistical result time and the set time caused by the data not being recorded at the moment of stage switching, and both the time and data are generated by the PLC, effectively avoiding the difference between the statistical result time and the set time caused by the time and data not being generated simultaneously, thereby improving the accuracy of the sterilization record time;

[0051] (2) The start time of the sterilization stage of the present invention is initiated between adding 400 to 600 milliseconds to the corresponding time, enabling an allowable error range of ±400 milliseconds, effectively avoiding the difference between the statistical result time and the set time caused by the timing error inside the PLC program, and further improving the accuracy of the sterilization record time;

[0052] (3) The present invention records historical data by the PLC at a fixed cycle and can dynamically adjust the historical data recording cycle of the PLC without software shutdown, thereby improving the flexibility of the historical record cycle change.

[0053] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting it; although the embodiments of the present invention are described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A method for recording sterilization data of a sterilization cabinet, characterized in that The database directly interacts with the PLC, including: The pulsating vacuum steam sterilizer operates according to the recipe data; When the pressure value and temperature value of the equipment reach the set values, the PLC records the start time and start data of the sterilization stage and sends them to the database; when the set operating time or the set F0 value is reached, the PLC records the end time and end data of the sterilization stage and sends them to the database; The actual duration of the sterilization stage is statistically obtained based on the start time and end time stored in the database, and the report data of the sterilization stage is formed accordingly.

2. The sterilization data recording method of the sterilization cabinet according to claim 1, characterized in that, The database and the PLC directly interact with each other through the TDS protocol.

3. The sterilization cabinet sterilization data recording method according to claim 1, characterized in that, It also includes: The PLC records the corresponding historical data according to the historical record period and sends the historical data and the corresponding time to the database.

4. The sterilization data recording method of the sterilization cabinet according to claim 3, wherein, The historical record period is adjustable.

5. The sterilization data recording method of the sterilization cabinet according to claim 1, characterized in that, The start time of the sterilization stage is between the corresponding minute + corresponding second + 400 - 600 milliseconds.

6. The method for recording sterilization data of a sterilization cabinet according to claim 1, characterized in that The set value of the pressure value is 1.05 bar, and the set value of the temperature value is 121.0 °C.

7. The method for recording sterilization data of a sterilization cabinet according to claim 1, wherein The set F0 value is 12.0 min, and the set operating time is 30 min.

8. The sterilization data recording method of the sterilization cabinet according to claim 1, wherein The pulsating vacuum steam sterilizer can select the working process. The working process includes multiple stages. The PLC records the corresponding time and data simultaneously at the change moment of each stage, obtains the start time, start data, end time and end data of each stage, and sends them to the database. The change moment of each stage is when the set operating condition requirements of each stage are met.

9. The sterilization data recording method of the sterilization cabinet according to claim 8, characterized in that, The working process includes "sterilization", "vacuum leak test" and "filter sterilization". The "sterilization" includes "liquid sterilization", "solid sterilization" and "BD sterilization". The stages included in the "liquid sterilization" are: standby, preheating, replacement, heating up, sterilization, exhaust and recompression; the stages included in the "solid sterilization" are: standby, preheating, pulsation, heating up, sterilization, exhaust, drying, pulsating drying and recompression; the stages included in the "BD sterilization" are: standby, preheating, pulsation, heating up, sterilization, exhaust, drying and recompression; the stages included in the "vacuum leak test" are: standby, evacuation, pressure stabilization, leak test and recompression; the stages included in the "filter sterilization" are: standby, pressure balance, heating up, sterilization, cooling and recompression.

10. A sterilization data recording system for a sterilization cabinet, characterized in that, Run the sterilizer sterilization data recording method according to any one of claims 1 - 9.